Abstract
Objective: The aim of this study was to assess clinical and hemodynamic outcomes of transapical aortic valve implantation (TA-TAVI) in patients enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Methods: From April 2008 until November 2010, 504 patients from 20 Italian centers were enrolled in the I-TA registry. Mean logistic EuroSCORE and Society of Thoracic Surgeons score were 24% ± 16% and 11% ± 4%, respectively. Mean follow-up was 9.2 ± 6.5 months (range, 1-26 months). Outcomes were analyzed according to intraoperative complications, procedural volume (high-volume centers, >20 cases; low-volume centers, <20 cases) and learning curve (first 50% cases vs second 50% cases of each center). Results: All-cause overall mortality was 8.3% (42 patients). Device success was 99% (500/504 patients). Intraoperative severe complications occurred in 24 (4.8%) patients. Overall 2-year survival was 71.5% ± 6.2%. At discharge, peak and mean gradients were 16.4 ± 11.2 and 8.7 ± 4.1 mm Hg, respectively, and effective orifice area was 1.67 cm2. These values remained stable at 3, 6, and 12 months after surgery. Independent risk factors for mortality after TA-TAVI were as follows: New York Heart Association class III and IV (odds ratio [OR], 4.43; 95% confidence intervals [CI], 1.28-15.40; P = .02); logistic EuroSCORE greater than 20 (OR, 1.83; 95% CI, 1.02-3.29; P = .04); creatinine concentration greater than 200 μmol/L (OR, 2.56; 95% CI, 1.07-6.15; P = .03), and intraoperative complications (OR, 5.80; 95% CI, 2.68-12.55; P <.001). There were no significant differences in outcomes between high- and low-volume centers and between the first and the second 50% of cases. Conclusions: TA-TAVI represents a safe and effective alternative treatment for patients who are inoperable or at high risk for surgery. The occurrence of an intraoperative complication significantly affects survival. Procedural volume and learning curve have no impact on patient survival.
| Original language | English |
|---|---|
| Pages (from-to) | 768-775 |
| Number of pages | 8 |
| Journal | Journal of Thoracic and Cardiovascular Surgery |
| Volume | 142 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - Oct 2011 |
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ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
- Surgery
- Pulmonary and Respiratory Medicine
Cite this
Clinical and hemodynamic outcomes of "all-comers" undergoing transapical aortic valve implantation : Results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). / D'Onofrio, Augusto; Rubino, Paolo; Fusari, Melissa; Salvador, Loris; Musumeci, Francesco; Rinaldi, Mauro; Vitali, Ettore O.; Glauber, Mattia; Di Bartolomeo, Roberto; Alfieri, Ottavio R.; Polesel, Elvio; Aiello, Marco; Casabona, Riccardo; Livi, Ugolino; Grossi, Claudio; Cassese, Mauro; Pappalardo, Aniello; Gherli, Tiziano; Stefanelli, Guglielmo; Faggian, Giuseppe G.; Gerosa, Gino.
In: Journal of Thoracic and Cardiovascular Surgery, Vol. 142, No. 4, 10.2011, p. 768-775.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Clinical and hemodynamic outcomes of "all-comers" undergoing transapical aortic valve implantation
T2 - Results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA)
AU - D'Onofrio, Augusto
AU - Rubino, Paolo
AU - Fusari, Melissa
AU - Salvador, Loris
AU - Musumeci, Francesco
AU - Rinaldi, Mauro
AU - Vitali, Ettore O.
AU - Glauber, Mattia
AU - Di Bartolomeo, Roberto
AU - Alfieri, Ottavio R.
AU - Polesel, Elvio
AU - Aiello, Marco
AU - Casabona, Riccardo
AU - Livi, Ugolino
AU - Grossi, Claudio
AU - Cassese, Mauro
AU - Pappalardo, Aniello
AU - Gherli, Tiziano
AU - Stefanelli, Guglielmo
AU - Faggian, Giuseppe G.
AU - Gerosa, Gino
PY - 2011/10
Y1 - 2011/10
N2 - Objective: The aim of this study was to assess clinical and hemodynamic outcomes of transapical aortic valve implantation (TA-TAVI) in patients enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Methods: From April 2008 until November 2010, 504 patients from 20 Italian centers were enrolled in the I-TA registry. Mean logistic EuroSCORE and Society of Thoracic Surgeons score were 24% ± 16% and 11% ± 4%, respectively. Mean follow-up was 9.2 ± 6.5 months (range, 1-26 months). Outcomes were analyzed according to intraoperative complications, procedural volume (high-volume centers, >20 cases; low-volume centers, <20 cases) and learning curve (first 50% cases vs second 50% cases of each center). Results: All-cause overall mortality was 8.3% (42 patients). Device success was 99% (500/504 patients). Intraoperative severe complications occurred in 24 (4.8%) patients. Overall 2-year survival was 71.5% ± 6.2%. At discharge, peak and mean gradients were 16.4 ± 11.2 and 8.7 ± 4.1 mm Hg, respectively, and effective orifice area was 1.67 cm2. These values remained stable at 3, 6, and 12 months after surgery. Independent risk factors for mortality after TA-TAVI were as follows: New York Heart Association class III and IV (odds ratio [OR], 4.43; 95% confidence intervals [CI], 1.28-15.40; P = .02); logistic EuroSCORE greater than 20 (OR, 1.83; 95% CI, 1.02-3.29; P = .04); creatinine concentration greater than 200 μmol/L (OR, 2.56; 95% CI, 1.07-6.15; P = .03), and intraoperative complications (OR, 5.80; 95% CI, 2.68-12.55; P <.001). There were no significant differences in outcomes between high- and low-volume centers and between the first and the second 50% of cases. Conclusions: TA-TAVI represents a safe and effective alternative treatment for patients who are inoperable or at high risk for surgery. The occurrence of an intraoperative complication significantly affects survival. Procedural volume and learning curve have no impact on patient survival.
AB - Objective: The aim of this study was to assess clinical and hemodynamic outcomes of transapical aortic valve implantation (TA-TAVI) in patients enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Methods: From April 2008 until November 2010, 504 patients from 20 Italian centers were enrolled in the I-TA registry. Mean logistic EuroSCORE and Society of Thoracic Surgeons score were 24% ± 16% and 11% ± 4%, respectively. Mean follow-up was 9.2 ± 6.5 months (range, 1-26 months). Outcomes were analyzed according to intraoperative complications, procedural volume (high-volume centers, >20 cases; low-volume centers, <20 cases) and learning curve (first 50% cases vs second 50% cases of each center). Results: All-cause overall mortality was 8.3% (42 patients). Device success was 99% (500/504 patients). Intraoperative severe complications occurred in 24 (4.8%) patients. Overall 2-year survival was 71.5% ± 6.2%. At discharge, peak and mean gradients were 16.4 ± 11.2 and 8.7 ± 4.1 mm Hg, respectively, and effective orifice area was 1.67 cm2. These values remained stable at 3, 6, and 12 months after surgery. Independent risk factors for mortality after TA-TAVI were as follows: New York Heart Association class III and IV (odds ratio [OR], 4.43; 95% confidence intervals [CI], 1.28-15.40; P = .02); logistic EuroSCORE greater than 20 (OR, 1.83; 95% CI, 1.02-3.29; P = .04); creatinine concentration greater than 200 μmol/L (OR, 2.56; 95% CI, 1.07-6.15; P = .03), and intraoperative complications (OR, 5.80; 95% CI, 2.68-12.55; P <.001). There were no significant differences in outcomes between high- and low-volume centers and between the first and the second 50% of cases. Conclusions: TA-TAVI represents a safe and effective alternative treatment for patients who are inoperable or at high risk for surgery. The occurrence of an intraoperative complication significantly affects survival. Procedural volume and learning curve have no impact on patient survival.
UR - http://www.scopus.com/inward/record.url?scp=81155161869&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=81155161869&partnerID=8YFLogxK
U2 - 10.1016/j.jtcvs.2011.06.026
DO - 10.1016/j.jtcvs.2011.06.026
M3 - Article
C2 - 21840020
AN - SCOPUS:81155161869
VL - 142
SP - 768
EP - 775
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
SN - 0022-5223
IS - 4
ER -